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PREVUE Y
HOYA MEDICAL SINGAPORE PTE. LTD. · Model PREVUE (yellow), +12.00D · UDI-DI 10757770564436
HQL
Prescription
5
510(k) clearances
0
Adverse events
75
Recalls
57
Facilities
Description
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-19 | AMO Puerto Rico Manufacturing, Inc. | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. |
| 2025-06-06 | Bausch & Lomb Surgical, Inc. | An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visua |
| 2025-03-27 | Bausch & Lomb Surgical, Inc. | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVist |
| 2023-07-06 | Johnson & Johnson Surgical Vision, Inc. | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. |
| 2022-05-13 | Rayner Intraocular Lenses Ltd | The outer package is mislabeled and the package contains a different IOL strength. |
| 2022-05-11 | Alcon Laboratories Ireland, Ltd | Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing li |
| 2020-06-09 | Bausch & Lomb Surgical, Inc. | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. |
| 2020-04-17 | Alcon Research LLC | Incorrect IOL diopter |
| 2018-11-09 | Tekia, Inc. | A limited number of lenses may be mislabeled with the incorrect diopter power. |
| 2018-11-05 | Bausch & Lomb Surgical, Inc. | Cosmetic imperfections on the surface of some lenses. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.